Grant Number:	1U01AR052155-01
PI Name:	Pilkonis, Paul A.
PI Email:	pilkonispa@upmc.edu
PI Title:	Professor of Psychiatry and Psychology
Project Title:	Pittsburgh PROMIS: Measuring Patient-Reported Sleep and Emotional Distress
Key Personnel:	Paul Pilkonis, PhD, Principal Investigator David Kupfer, MD, Co-Principal Investigator Daniel Buysse, MD, Co-Investigator Jill Cyranowski, PhD, Co-Investigator Mary Amanda Dew, PhD, Co-Investigator Sue Eisen, PhD, Co-Investigator Anne Germain, PhD, Co-Investigator Frank Ghinassi, PhD, Co-Investigator Victoria Grochocinski, PhD, Co-Investigator Mary Lou Klem, PhD, Co-Investigator Douglas Moul, MD, MPH, Co-Investigator Thomas Rudy, PhD, Co-Investigator Wesley Thompson, PhD, Co-Investigator David Weiss, PhD, Co-Investigator Angela Stover, MA, Project Coordinator Nathan Dodds, BS, Research Specialist Keri Hirtz, BA, Research Specialist Kelly Macko, BA, Research Project Assistant Internal Consultants: Scott Beach, PhD, Internal Consultant Timothy Monk, DSc, PhD, Internal Consultant External Consultants: Glorisa Canino, PhD, External Consultant Daniel Ford, MD, MPH, External Consultant Robert Gibbons, PhD, External Consultant
Web Site:	http://wpic.upmc.com

Abstract: Sleep-wake function (SWF) is a fundamental biological process with known physiological regulatory mechanisms. A large number of physical and mental disorders disturb SWF, and such disturbances are associated with negative health outcomes and adverse effects on health-related quality of life. Therefore, any assessment of patient-related outcomes should include a careful assessment of SWF. Currently, however, there is no widely accepted, comprehensive measure of patient-reported outcomes in SWF. The aims of this independent project are (1) to develop an archive of self-report measures that assess SWF, (2) to develop an item bank from these measures that comprehensively assesses the major features of SWF, (3) to test the SWF item bank in broad samples of subjects (i.e., sleep disorder patients, psychiatric patients, community participants) to determine its dimensionality and to identify the psychometric properties of the items using item response theory (IRT) models, (4) to develop a computerized adaptive testing (CAT) format for the SWF scales, and (5) to examine the validity of the new scales against prospective self-report (sleep diary) and objective (actigraphy) data. We propose three iterative waves of data collection, IRT calibration, and development of CATs, followed by a fourth wave of longitudinal data collection (three assessments over a 12-month period). Prospective data will allow us to examine the relationship between global self-reports about SWF compared to daily sleep-wake diaries and actigraphy, an objective index of sleep-wake behavior. The resources available through PROMIS will permit rapid development and testing of a SWF instrument in a large number of subjects with a wide range of medical and psychiatric conditions. The final CAT product will help to standardize assessments of SWF across research studies and clinical care.

We also propose to participate in PROMIS network projects focused on (1) articulating the domain of emotional distress—including both internalizing symptoms (depression and anxiety) and externalizing symptoms (anger aggression and substance use), (2) performing analyses of differential item functioning on the items for emotional distress contingent on important demographic (e.g., sex, age, race) and clinical (e.g., medical status) variables, and (3) identifying relationships among IRT-calibrated measures of emotional distress, pain, and social functioning.